Safety and Efficacy of Faricimab in Patients With NPDR (NCT05681884) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Faricimab in Patients With NPDR
United States179 participantsStarted 2023-05-16
Plain-language summary
The purpose of this Phase 2 study is comprised of two groups to evaluate the safety, tolerability, and efficacy of faricimab in patients with Non-Proliferative Diabetic Retinopathy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provide signed IRB-approved informed consent form (ICF) prior to any study-specific procedures
* Willing and able to comply with clinic visits and study-related procedures and likely to return for all study visits, in the investigator's judgement
* Men or women \> 18 years of age at the time of signing the Informed Consent Form
* Diagnosis of diabetes mellitus (type 1 or type 2)
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the final dose of study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a post-menopausal state (\>12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of acceptable contraceptive methods include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
Contraception methods that do not result in a failure rate of \< 1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spe…